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Special Access & Exceptional Use

Thai FDA · MDCD · Medical Device Act B.E. 2562 · Emergency authorisation

Overview​

The Medical Device Act B.E. 2562 provides for certain exceptional circumstances in which devices may be used or imported without standard registration. These are narrow exceptions — the standard registration pathway is the primary route for commercial distribution.

Emergency Authorisation​

In a declared public health emergency (domestic or international, such as an outbreak or disaster), Thai FDA/MDCD may grant emergency authorisation for:

  • Devices that are not registered in Thailand but are needed urgently
  • Expedited use of registered devices beyond their normal conditions

Emergency authorisations are time-limited, condition-specific, and do not substitute for standard registration once the emergency period ends. Coordinate with MDCD directly if an emergency situation arises.

Compassionate Use / Individual Patient Access​

Unregistered devices may be imported and used for individual patients in life-threatening or serious conditions where:

  • No registered equivalent is available in Thailand
  • The treating physician determines the device is necessary for the specific patient
  • MDCD approval is obtained before importation

The application for individual patient access is submitted by the treating physician or hospital, not the manufacturer or distributor. Quantity is limited to the individual patient's needs.

Clinical Investigation Devices​

Devices used in clinical investigations (clinical trials) in Thailand are exempt from standard registration requirements during the investigation period, provided:

  • The clinical investigation has been approved by a Thai Institutional Review Board (IRB) and by Thai FDA/MDCD
  • The device is used only within the approved investigation protocol
  • The investigational sponsor complies with Good Clinical Practice (GCP) requirements
  • Adverse events occurring during the investigation are reported per the approved protocol and to MDCD

Clinical investigation approval is required before any patient exposure. Contact MDCD's clinical investigation unit for application requirements.

Import for Research and Demonstration​

Devices imported for research purposes (laboratory testing, non-clinical evaluation) or demonstration (not for commercial sale or patient use) may be imported without registration, subject to:

  • Quantity limits appropriate for research/demonstration purposes
  • The device is not used on patients outside an approved clinical investigation
  • Import documentation confirming the purpose

Confirm import quantity limits and documentation requirements with Thai Customs and MDCD.

Personal Importation​

Individuals may import a device for personal use in limited quantities:

  • The device must be for the individual's own use — not for commercial distribution
  • Quantity must be consistent with personal use (not commercial scale)
  • Some high-risk devices may not be eligible for personal importation

This route is not intended for commercial market entry — any commercial distribution requires standard registration.

Key Contact​

For special access enquiries: Thai FDA/MDCD — Division of Medical Device Control — fda.moph.go.th. All special access requests should be made in writing to MDCD before proceeding.